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U.S. Department of Health and Human Services

Class 1 Device Recall Handy Solutions Heating Pad Neck and Shoulders

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 Class 1 Device Recall Handy Solutions Heating Pad Neck and Shoulderssee related information
Date Initiated by FirmFebruary 18, 2026
Date PostedMarch 21, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1588-2026
Recall Event ID 98453
Product Classification Pad, heating, powered - Product Code IRT
ProductHandy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd
Code Information UPC: 0-24291-25607-6, UDI-DI: 00024291256076
FEI Number 1000065475
Recalling Firm/
Manufacturer
Navajo Manufacturing Company
5330 Fox St
Denver CO 80216-1630
For Additional Information Contact
303-292-3090
Manufacturer Reason
for Recall
If heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures, which can also be caused by placing pad under the body, then the high limit device is unable to sense the higher temperature so power is not terminated. May cause a burning smell prior to melting/burning potentially causing burns to persons and property.
FDA Determined
Cause 2
Device Design
ActionOn 2/18/2026 a recall notice was emailed to one customer who was asked to do the following: Begin processes for notifying your distributors/customers who were shipped affected devices. They should return all unsold units to the recalling firm. Your customers should begin to notify their customers as well to discontinue use of the product. A Consumer Recall Notice will be included as a separate file that can be provided to the consumer. Retailers should notify consumers who received the recalled heating pad to immediately discontinue use of the heating pad, cut the heating pad s cord, and dispose of the heating pad. Consumers should immediately discontinue use of the heating pad. The heating pad's cord should be cut and the heating pad disposed of. The consumer will be contacted by the platform through which they purchased the heating pads to arrange replacement from a different manufacturer. Complete and return the Acknowledgement and Receipt Form to fmorales@navajoinc.com If you have questions, firm can be contacted via phone: 1-800-525-5097, or email: heatingpadrecall@navajoinc.com
Quantity in Commerce28,457
DistributionUS Nationwide distribution in the states of CA, MS, FL, IN, LA, VA, TX.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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